Dear OMIC Insureds:

RISK ISSUE
Instituting a time-out process is known to increase patient safety by reducing wrong site, wrong procedure, wrong medication, and wrong patient errors. Compliance with the time-out process is essential to reduce human errors and system process gaps to ultimately eliminate preventable adverse events. The Joint Commission (TJC), World Health Organization (WHO), and OMIC all have developed surgical safety checklists that will assist you in implementing a systematic time-out process in your practice.

BACKGROUND
The Joint Commission (TJC) implemented the Universal Protocol in 2003 to reduce wrong events. The protocol has three elements: pre-procedure verification process, marking the procedure site, and time-out. The first two elements are important to ensure the time-out process is smooth. Pre-procedure verification includes confirming with the patient – BEFORE sedation – the patient’s name, the procedure to be performed, and site (left, right, bilateral). The marking of the site should be completed by the physician (or accountable licensed practitioner) with the patient’s participation. The time-out process should include every member of the procedural team. An individual on the team should be designated to lead the time-out. Everyone on the team should agree before proceeding and be encouraged to speak up if discrepancies are found.

The World Health Organization (WHO) developed a Surgical Checklist that also has three sections. The first, before induction of anesthesia, includes having the patient confirm their identity, site, procedure, and consent, and marking the site. In the second, before skin incision, the surgical team confirms the patient’s name, procedure, and site. As part of the third step, before the patient leaves the operating room, the team orally confirms the procedure performed.

OMIC and the American Academy of Ophthalmology formed a task force in 2012 to develop an ophthalmic-specific surgical safety checklist with the following three sections: sign-in (before anesthesia), time-out (before incision), and sign-out (before leaving the operating room). These checklists can be tailored to your specific practice based on your patient population, procedures performed, anesthesia administered, and procedure location. The time-out process is not time-consuming, but must be carried out thoroughly, with focus on each step, to help reduce or eliminate wrong events.

ASSESSMENT
Failing to institute a systematic, consistent time-out process in your practice can potentially lead to patient safety and liability exposures related to wrong site, wrong procedure, wrong medication, and wrong patient errors. Failure to use, or follow, timeout protocols and surgical checklists have resulted in OMIC claims against, and indemnity payments made on behalf of, insureds. TJC requires a comprehensive analysis of wrong-site surgeries in their accredited facilities. In a 2023 published study, they analyzed the contributing factors that led to these errors and found that 83.8% were due to failure to follow policy/protocol and 41.2% for failure to review the medical record. Performing a gap analysis in your facility, and developing risk mitigation strategies to fill those gaps can prevent an adverse event. Establishing evidence-based processes and creating a culture of safety will lead to improved patient safety and a reduction of liability exposure.

RISK RECOMMENDATIONS

• Develop a surgical safety checklist, using the above resources as guides, which includes a time-out process to ensure correct patient, procedure, medication, and site.
• Safety checklists should be used for procedures in the office and in the OR.
• Train all staff in the elements of the surgical safety checklist.
• Identify who will lead the time-out and consistently follow the process.
• Empower the procedural staff to speak up if there are inconsistencies identified.
• Audit compliance with your surgical safety checklist.

RESOURCES
OMIC Risk Management Recommendations- Time-Outs for Procedures
OMIC Surgical Checklist
OMIC Insured Time-Out Video
WHO Surgical Safety Checklist
TJC UP
AORN
ASCA

If you have questions, contact us for confidential risk management advice at riskmanagement@omic.com or call us at 1-800-562-6642 and enter 4 for Risk Management.

Sincerely,

Hans K. Bruhn, MHS
OMIC Risk Manager
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